MAUDE Adverse Event Report: ABBOTT MEDICAL KIT IMPLANTABLE SLIM TIP LEAD, 90CM; DRG LEAD

Model Number MN10450-90A

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/21/2023

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported that during a lead replacement procedure (related manufacturer reference number: 1627487-2023-03797) the physician couldn¿t not remove the distal portion of the l1 fractured lead including the contacts sheared.Therefore, the lead was not pulled out completely and portions are still in the epidural space.Intervention is not planned to remove the lead portion.

• Brand Name: KIT IMPLANTABLE SLIM TIP LEAD, 90CM
• Type of Device: DRG LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 17946933
• MDR Text Key: 325795641
• Report Number: 1627487-2023-04912
• Device Sequence Number: 1
• Product Code: PMP
• UDI-Device Identifier: 05415067027160
• UDI-Public: 05415067027160
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MN10450-90A
• Device Lot Number: 8562754
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/21/2023
• Initial Date FDA Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DRG IPG; DRG LEAD (3)
• Patient Outcome(s): Other
• Patient Age: 34 YR
• Patient Sex: Female
• Patient Weight: 49 KG